tbuckley/cabot-search huggingface dataset:
Results of a multicenter, randomized, phase 3 trial of trimodality therapy with I-125 brachytherapy, external beam radiation therapy, and long- versus short-term androgen deprivation therapy for localized high-risk prostate cancer (TRIP/TRIGU0907).
Authors: Atsunori Yorozu, Mikio Namiki, Shiro Saito, Shin Egawa, Hiroshi Yaegashi, Konaka Hiroyuki, Tetsuo Momma, Takashi Fukagai, Nobumichi Tanaka, Toshio Ohashi, Hiroyuki Takahashi, Atsushi Mizokami, Yoko Nakagawa, Takashi Kikuchi, Nelson Stone
Journal: Journal of Clinical Oncology (2023)

305 Background: The TRIP trial was a multicenter, phase 3 randomized investigation designed to determine whether 30 months of androgen deprivation therapy (ADT) was superior to 6 months of ADT when combined with brachytherapy and external beam radiotherapy (EBRT) for localized high-risk prostate cancer. Methods: The trial was done in 37 hospitals in Japan. Men between 40 to 79 years old with stage T2c-3a, or a prostate-specific antigen (PSA) &gt;20 ng/ml or a Gleason score &gt;7 received 6 months of ADT combined with I-125 brachytherapy at a prescription dose of 110 Gy, followed by EBRT of 45 Gy. Patients were randomly assigned either no further treatment (short arm) or 24 months of adjuvant ADT (long arm) after stratification. The primary endpoint was biochemical progression-free survival using the Phoenix definition of failure. Secondary endpoints included clinical progression, metastasis, salvage treatment, disease-specific survival, overall survival, and grade 3 or higher of adverse events. An intention-to-treat analysis was conducted with survival estimates determined using competing risk analyses. Results: Of 332 patients, 165 were randomized to the short and 167 to the long arm. The median follow-up periods were 9.43 and 9.24 years, respectively. 24 patients have died in each arm. The cumulative incidence for biochemical progression in the short vs. long arm were 10.4% (95% confidence interval [CI] 6.62-16.42) vs 9.5% (5.85-15.46) at 9 years, respectively (p=0.647). The cumulative incidences for clinical progression, distant metastases, salvage treatment, and disease-specific mortality events were not significantly different between the two arms. The overall survival rates of the short arm vs long arm were 87.2% (82.13-92.63%) and 85.9% (80.41-91.77%) at 9 years, respectively (p=0.914). Endocrine-related grade 3 morbidity for short arm vs long arm was 0.6% vs 1.8% (p=0.623), and radiation-related grade 3 morbidity was 1.2% vs 0.6% (p=0.622). Conclusions: In localized high-risk prostate cancer, TRIP did not demonstrate the superiority of 30 months vs. 6 months of ADT when combined with brachytherapy and EBRT. These data suggest that ultra-high radiation doses can be combined with a shorter course of ADT without compromising survival. Clinical trial information: UMIN000003992 .
Prognostic stratification by the Meet-URO score in a real-world elderly population of patients (pts) with metastatic renal cell carcinoma (mRCC) receiving cabozantinib: A subanalysis of the prospective ZEBRA study (Meet-URO 9).
Authors: Alessandra Damassi, Malvina Cremante, Giuseppe Fornarini, Alessio Signori, Sebastiano Buti, Umberto Basso, Giuseppe Procopio, Marco Maruzzo, Mariella Sorarù, Marilena Di Napoli, Lucia Fratino, Daniele Santini, Francesco Grillone, Melissa Ballestrin, Michele Dionese, Veronica Murianni, Fabio Catalano, Giuseppe Luigi L. Banna, Pasquale Rescigno, Sara Elena Rebuzzi
Journal: Journal of Clinical Oncology (2023)

637 Background: The combination of neutrophil to lymphocyte (NLR), bone metastases and IMDC score in the novel prognostic Meet-URO score has shown a higher prognostic performance than the IMDC score alone in mRCC pts receiving ≥2 nd line nivolumab or cabozantinib in two retrospective analyses and 1 st line nivolumab-ipilimumab in a real-world prospective study [http://bit.ly/Meet-URO15_score]. Further validation is needed since this score represents an easy prognostic tool for clinical practice with no additional costs. Methods: A real-world analysis of elderly (≥70 yo) mRCC pts treated with any line cabozantinib was conducted in the multicenter observational prospective Zebra study. Baseline Meet-URO score was assessed. The primary endpoint was overall survival (OS) and the Harrell’s c-index was calculated to compare accuracy of survival prediction of the Meet-URO and IMDC scores. Results: 104 mRCC pts received cabozantinib as 1 st (38%), 2 nd (20%), 3 rd (33%) and 4 th (8%) line, with a median follow-up of 11.2 months (mo) and a median overall survival (mOS) of 18.4 mo. According to the IMDC score, favorable- (15%), intermediate- (65%) and poor-risk (19%) pts had a mOS not reached (NR), 15.6 and of 5.7 mo, respectively (p = 0.011). Reclassifying the population according to the Meet-URO score, we observed that group 1 (10%) and group 2 (25%) had both mOS NR, whereas group 3 (33%), group 4 (25%) and group 5 (8%) had a mOS of 13.6, 12.5 and 3.7 mo, respectively (p = 0.001). Moreover, the Meet-URO score maintained its discrimination ability also merging group 1-2 vs 3-4 vs 5 (p &lt; 0.001). NLR &lt; 3.2 was the heaviest component of the score (p &lt; 0.001, mOS 24.8 vs 11.5 mo). The Meet-URO score (using both original with 5 groups and modified with 3 groups) has shown a higher prognostic power than the IMDC score alone (c-index of 0.686 and 0.676 vs 0.622). Conclusions: This analysis confirmed the higher accuracy in survival stratification of the Meet-URO score compared with the IMDC score alone also in a specific population like elderly mRCC pts treated with cabozantinib. NLR was confirmed as a strong prognostic factor with cabozantinib. Further applications of the Meet-URO score in mRCC pts treated with first-line immune-combinations are planned and highly awaited. Clinical trial information: 2018/116/PU .
A study to determine enzalutamide long term safety and efficacy for men with castration-resistant prostate cancer: A multicenter, prospective DELC study.
Authors: Koji Hatano, Akira Nagahara, Wataru Nakata, Mototaka Sato, Tetsuya Takao, Soichi Matsumura, Kensaku Nishimura, Shingo Takada, Toshichika Iwanishi, Yasuyuki Kobayashi, Yu Ishizuya, Tsuyoshi Takada, Koichi Okada, Hitoshi Inoue, Motohide Uemura, Norio Nonomura
Journal: Journal of Clinical Oncology (2023)

66 Background: In the PREVAIL study, enzalutamide was demonstrated to be effective in men with chemo-naïve metastatic castration-resistant prostate cancer (CRPC). In Japan, enzalutamide was introduced in 2014. Real-world evidence is needed for the long-term safety and efficacy of enzalutamide. The aim of this study was to evaluate the efficacy, safety and prognostic factors in CRPC treated with enzalutamide. Methods: This multicenter, prospective, observational study enrolled 163 Japanese CRPC patients between January 2016 and March 2019. Eligibility criteria were men with chemo-naïve CRPC, no prior treatment with novel androgen receptor signaling inhibitors, and an ECOG- Performance Status ≤ 2. The switching of bicalutamide and flutamide was eligible. Written consent for participation has been obtained from the patient. Enzalutamide 160 mg/day was administered once daily according to usual practice. Data were collected from medical records at baseline and every 3 months until march 2021. The primary endpoint was overall survival (OS), and factors associated with OS were examined. Cox proportional hazards model was used for statistics. The secondary endpoints were PSA response and safety. Results: At a median follow-up of 26.0 months, the median OS was 42.1 months and 24-month OS rate was 69%. Univariate analysis showed that time to CRPC, pretreatment serum PSA, baseline NSE, and baseline interleukin-6 (IL-6) levels were associated with OS. Multivariate analysis revealed that pretreatment serum PSA (hazard ratio [HR] 2.30, 95% confidence interval [CI] 1.30-4.10), baseline NSE (HR 2.97, 95%CI 1.24-7.11), and baseline IL-6 (HR 2.32 95%CI 1.32-4.09) were independent risk factors for OS. PSA decline more than 50% was 74% (n=120). Fatigue (30%, n=49), constipation (20%, n=32) and appetite loss (18%, n=29) were the most common adverse events (AEs). Dose reduction/drug discontinuation rates were 20% (n=33) due to AEs and 18% (n=29) due to patient request. Conclusions: The efficacy and safety of enzalutamide in Japanese real clinical practice were comparable to those reported in PREVAIL study. The present analysis also suggests that serum PSA, NSE and IL-6 levels are independent prognostic factors in CRPC patients. Clinical trial information: UMIN000019855 . [Table: see text]
PARP Inhibitors “Remain Relevant” for mCRPC
Journal: Cancer Discovery (2023)

Phase III findings from TRITON3 and TALAPRO-2 bear out the efficacy of PARP inhibitors in men with metastatic castration-resistant prostate cancer, particularly those harboring BRCA1/2 alterations. Compared with standard care, rucaparib-and separately, the addition of talazoparib to enzalutamide-extended radiographic progression-free survival with manageable side effects.
Interim analysis of the prospective COTRIMS (Cologne Trial of Retroperitoneal Lymphadectomy in Metastatic Seminoma) trial.
Authors: Axel Heidenreich, Felix Seelemeyer, Pia Paffenholz, David A. Pfister
Journal: Journal of Clinical Oncology (2023)

409 Background: Radiation therapy or systemic chemotherapy with 3 cycles PEB represent the guideline recommended treatment options in marker negative clinical stage IIA/B seminoma. Despite a high cure rate of 90% to 94% and 82% to 90% in CS IIA and IIB, respectively, both therapeutic options are associated with significant long-term toxicities. It was the aim of our trial to evaluate the feasibility, oncological efficacy and treatment associated morbidity of primary nsRPLND in stage IIA/B seminoma. Methods: 30 patients with marker negative clinical stage IIA and IIB classical seminoma of the testis were recruited in the prospective trial. Primary goal was a relapse rate &lt;20% within 2 years follow-up. Exclusion criteria were adjuvant carboplatin therapy for clinical stage I disease, extensive clinical stage IIb or clinical stage IIC disease, previous retroperitoneal surgery or radiation therapy, and positive tumor markers. All patients underwent nerve sparing RPLND with a modified template resection. None of the patients received adjuvant chemotherapy in the presence of positive lymph nodes. All patients underwent close follow-up with imaging studies and tumor markers at 3-month intervals during the first 2 years, at 6-month intervals in year 3 and annually thereafter. 10 pts had preoperative serum analysis of miR371. Results: Mean age was 34.2 (21-54) years. Mean follow-up is 29.4 (1-60) months and 32.5 (3-60) for those with a minimum follow-up of 3 months. All patients were treatment-naïve; 19 and 11 patients were diagnosed with stage IIA and IIB disease, respectively, at time of RPLND. 28 and 2 patients underwent open and robot assisted ns RPLND, respectively. Mean OR time was 131 (105-195) min, mean blood loss was &lt; 150ml and the mean hospitalization time was 4.5 (3-9) days. We did not observe surgery associated complications &gt; Clavien Dindo grade 3a. Mean number of dissected lymph nodes was 18 (7-57), the mean number of positive lymph nodes was 1.3 (1-2) and the mean diameter of positive nodes was 2.3 (0.8-4.1) cm. Histology of the resected lymph nodes revealed metastatic seminoma in 25 (80%) patients; 2 and 3 patients demonstrated embryonal carcinoma and benign disease, resp. 10 pts underwent serum analysis of miR371 preoperatively which predicted metastatic disease in 9/10 and benign histology in 1/1. 2/30 (6.7%) patients developed an outfield relapse 4 and 6 months postoperatively. Both patients were salvaged by systemic chemotherapy with 4 cycles PEB. Conclusions: NsRPLND results in a high cure rate at midterm follow-up and it is associated with a low frequency of treatment associated morbidities making this approach a feasible alternative to standard radiation therapy or systemic chemotherapy. MiR371p might be a useful marker to predict presence/absence of metastases in equivocal findings. Clinical trial information: DRKS00025384 .
Characteristics of patient navigation programs in the Cancer Moonshot ACCSIS colorectal cancer screening initiative
Authors: Gloria D Coronado, Renée M Ferrari, Autumn Barnes, Sheila F Castañeda, Mark Cromo, Melinda M Davis, Mark P Doescher, Kevin English, Jenna Hatcher, Karen E Kim, Sarah Kobrin, David Liebovitz, Shiraz I Mishra, Jesse N Nodora, Wynne E Norton, Jill M Oliveri, Daniel S Reuland, Sujha Subramanian, Jamie H Thompson, Electra D Paskett
Journal: JNCI Journal of the National Cancer Institute (2023)

Although patient navigation has shown promise for increasing participation in colorectal cancer screening and follow-up, little evidence is available to guide implementation of patient navigation in clinical practice. We characterize 8 patient navigation programs being implemented as part of multi-component interventions of the National Cancer Institute's Cancer Moonshot Accelerating Colorectal Cancer Screening and Follow-Up Through Implementation Science (ACCSIS) initiative.We developed a data collection template organized by ACCSIS framework domains. The template was populated by a representative from each of the 8 ACCSIS research projects. We report standardized descriptions of 1) the socio-ecological context in which the navigation program was being conducted, 2) navigation program characteristics, 3) activities undertaken to facilitate program implementation (eg, training), and 4) outcomes used in program evaluation.ACCSIS patient navigation programs varied broadly in their socio-ecological context and settings, the populations they served, and how they were implemented in practice. Six research projects adapted and implemented evidence-based patient navigation programs; the remaining projects developed new programs. Five projects began navigation when patients were due for initial colorectal cancer screening; 3 projects began navigation later in the screening process, when patients were due for follow-up colonoscopy after an abnormal stool-test result. Seven projects relied on existing clinical staff to deliver the navigation; 1 hired a centralized research navigator. All project researchers plan to evaluate the effectiveness and implementation of their programs.Our detailed program descriptions may facilitate cross-project comparisons and guide future implementation and evaluation of patient navigation programs in clinical practice.
Surgical Procedural Definitions for Hidradenitis Suppurativa Developed by Expert Delphi Consensus
Authors: Helen Bui, Falk G. Bechara, Ralph George, Stephanie Goldberg, Iltefat Hamzavi, Joslyn S. Kirby, Drew Saylor, Christopher J. Sayed
Journal: JAMA Dermatology (2023)

Importance Various surgical approaches for hidradenitis suppurativa (HS) have been described in the literature, but the nomenclature is inconsistent. Excisions have been described as wide, local, radical, and regional with variable descriptions of margins. Deroofing procedures have been described with various approaches though descriptions of the approach are generally more uniform. No international consensus has been formed to globally standardize terminology for HS surgical procedures. Lack of such agreement may contribute to misunderstanding or misclassification in HS procedural research studies and impair clear communication among clinicians or between clinicians and patients. Objective To create a set of standard definitions for HS surgical procedures. Design, Setting, and Participants This consensus agreement study was conducted from January to May 2021 using the modified Delphi consensus method to reach agreement among a group of international HS experts regarding standardized definitions for an initial set of HS surgical terms, including “incision and drainage,” “deroofing/unroofing,” “excision,” “lesional excision,” and “regional excision,” ultimately expanded to 10 terms. Provisional definitions were drafted based on existing literature and discussion among an expert 8-member steering committee. Online surveys were disseminated to members of the HS Foundation, direct contacts of the expert panel, and the HSPlace listserv to reach physicians with considerable experience with HS surgery. Consensus was defined as greater than 70% agreement to accept a definition. Results In the first and second modified Delphi round, 50 and 33 experts participated, respectively. Ten surgical procedural terms and definitions reached consensus with greater than 80% agreement. Overall, the term “local” excision was abandoned and replaced with the descriptors “lesional” or “regional” excision. Of note, “regional” replaced the terms “wide” and “radical” excision. Furthermore, modifiers such as “partial” vs “complete” should also be included when describing surgical procedures. A combination of these terms helped formulate the final glossary of HS surgical procedural definitions. Conclusion and Relevance An international group of HS experts agreed on a set of definitions describing surgical procedures frequently used by clinicians and in the literature. The standardization and application of such definitions are vital to allow for accurate communication, reporting consistency, and uniform data collection and study design in the future.
Shared Decision-making, Therapeutic Choice and Decisional Regret in Alopecia Areata—Where Narrative Ethics Meets the Unconscious Bias of Clinicians—Reply
Authors: Kathie Huang, Arash Mostaghimi
Journal: JAMA Dermatology (2023)

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Association of the COVID-19 Pandemic With Unstable and/or Unsafe Living Situations and Intimate Partner Violence Among Pregnant Individuals
Authors: Lyndsay A. Avalos, G. Thomas Ray, Stacey E. Alexeeff, Sara R. Adams, Monique B. Does, Carey Watson, Kelly C. Young-Wolff
Journal: JAMA Network Open (2023)

Importance The social, behavioral, and economic consequences of the COVID-19 pandemic may be associated with unstable and/or unsafe living situations and intimate partner violence (IPV) among pregnant individuals. Objective To investigate trends in unstable and/or unsafe living situations and IPV among pregnant individuals prior to and during the COVID-19 pandemic. Design, Setting, and Participants A cross-sectional population-based interrupted time-series analysis was conducted among Kaiser Permanente Northern California members who were pregnant and screened for unstable and/or unsafe living situation and IPV as part of standard prenatal care between January 1, 2019, and December 31, 2020. Exposures COVID-19 pandemic (prepandemic period: January 1, 2019, to March 31, 2020; during pandemic period: April 1 to December 31, 2020). Main Outcomes and Measures The 2 outcomes were unstable and/or unsafe living situations and IPV. Data were extracted from electronic health records. Interrupted time-series models were fit and adjusted for age and race and ethnicity. Results The study sample included 77 310 pregnancies (74 663 individuals); 27.4% of the individuals were Asian or Pacific Islander, 6.5% were Black, 29.0% were Hispanic, 32.3% were non-Hispanic White, and 4.8% were other/unknown/multiracial, with a mean (SD) age of 30.9 (5.3) years. Across the 24-month study period there was an increasing trend in the standardized rate of unsafe and/or unstable living situations (2.2%; rate ratio [RR], 1.022; 95% CI, 1.016-1.029 per month) and IPV (4.9%; RR, 1.049; 95% CI, 1.021-1.078 per month). The ITS model indicated a 38% increase (RR, 1.38; 95% CI, 1.13-1.69) in the first month of the pandemic for unsafe and/or unstable living situation, with a return to the overall trend afterward for the study period. For IPV, the interrupted time-series model suggested an increase of 101% (RR, 2.01; 95% CI, 1.20-3.37) in the first 2 months of the pandemic. Conclusions and Relevance This cross-sectional study noted an overall increase in unstable and/or unsafe living situations and IPV over the 24-month period, with a temporary increase associated with the COVID-19 pandemic. It may be useful for emergency response plans to include IPV safeguards for future pandemics. These findings suggest the need for prenatal screening for unsafe and/or unstable living situations and IPV coupled with referral to appropriate support services and preventive interventions.